Determining the impact of peer-led, community-based PrEP delivery among youth in Brazil: A randomized controlled trial - SUMMARY/ABSTRACT HIV is declining in many parts of the world, but rising in Latin America, including Brazil. From 2010 to 2019, the number of new HIV infections in Latin America increased 21%, compared to a global reduction of 23%. The number of reported HIV cases in Brazil increased from 13,719 in 2011 to 40,880 in 2021, with increases driven by youth aged 15-24 years. Among men aged 15-24 years, HIV incidence per 100,000 increased from 37.8 in 2000 to 66.5 in 2018 – a 75% increase. HIV pre-exposure prophylaxis (PrEP) was approved in Brazil in 2021 for adolescents aged 15-17 years, but PrEP uptake has been <1% among youth. Our team conducted the first and largest PrEP demonstration study among adolescents in Latin America (PrEP1519), in which we implemented peer navigation strategies that linked 1174 youth (20% of 5870 recruited) to PrEP services at health facilities. In qualitative interviews, youth articulated positive relationships with peer navigators but reluctance to engage with facility-based services due to past experiences with stigma and logistical and structural challenges accessing care. These data suggest that programs featuring peers were welcomed, but alternatives to facility-based services are urgently needed to scale up PrEP among youth. We hypothesize that equipping peer lay workers – trained youth who are integrated into health care teams – to deliver PrEP in community venues will increase PrEP uptake among youth. The goal of this project is to conduct a series of studies to refine, test, and understand experiences with a peer-led community-based intervention (CommunityPrEP, “COMPrEP”). In Aim 1, we will conduct qualitative interviews guided by the Consolidated Framework for Implementation Research to identify key modifications for the PrEP1519 peer navigator intervention to adapt it for community delivery by peer lay workers. In Aim 2, we will randomize 1400 youth who can benefit from PrEP to access PrEP through peer lay workers at community venues (COMPrEP intervention) or health providers at health facilities (standard care). We will conduct intent-to-treat analyses with modified Poisson regression to compare PrEP uptake (primary outcome) across randomized arms. We will follow the subset that initiates PrEP (expected to be N~385) for 12 months to compare secondary outcomes (1-month adherence, 3-month and 12-month persistence). Throughout the trial, we will monitor participant safety through our study team and an external monitoring board. In Aim 3, we will use the RE-AIM framework to explore experiences with the COMPrEP intervention through qualitative interviews with youth, peer lay workers and health providers, and local and national policymakers to develop next steps. The proposed work will provide robust evidence about whether PrEP delivery facilitated by peer lay workers in community settings increases PrEP uptake, adherence, and persistence among youth in Brazil. With members of the National HIV Program in Brazil as our collaborators, we will be well-positioned to provide results to guide programming for this population and scale up the intervention if effective.
